Plastic Injection Molding Development Engineer
hace 2 semanas
We are seeking a talented Plastic Injection Molding Development Engineer to join our team at Viant Medical.
About the RoleThis is an exciting opportunity for a motivated individual to contribute to the development and implementation of new molding processes and improvements to existing ones. As a Plastic Injection Molding Development Engineer, you will work closely with cross-functional teams to ensure seamless integration and compliance with regulatory requirements.
Main Responsibilities- Support in planning, developing, and implementing new molding development activities and changes to existing manufacturing processes related to the molding area.
- Prepare validation protocols and reports, work instructions, and applicable documentation required to sustain manufacture.
- Contribute to qualification and validation activities for new products, processes, changes, and transfers as per FDA regulations (IQ, OQ, and PQ).
- Assist in equipment, molds, and materials specifications for new molding processes, existing processes, or process changes, ensuring part designs can be injection molded economically and reliably. Provide support in cost estimation & timing for the procurement of capital equipment.
- Initiate Device History Record (documentation required for manufacturing).
- Troubleshoot existing molding processes for quality issues typical to the injection molding industry.
- Participate in the analysis of new and existing manufacturing processes and recommend improvements to maximize quality and productivity. Implement approved recommendations by fabricating custom fixtures, creating necessary documentation, directing efforts of outside resources.
- Training of Molding and Quality Assurance personnel on proper use of fixtures and molding process.
To be successful in this role, you should have:
- A Senior student BS in Engineering or related field.
- Knowledge on ISO 13485 and CRF 820 CGMPs (desired).
- English proficiency of 80% or higher.
The following skills and qualifications are highly valued:
- Project Management.
- Customer Focused Quality.
- Quality Engineering Statistical Tools.
- Reliability Engineering Statistical Tools.
- Influence Management.
- Working knowledge of statistical techniques.
- Working knowledge of quality and reliability software.
- Ability to work in a team environment.
- Working knowledge in spreadsheets, databases, and word processing software programs.
Viant Medical provides equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, nationality, age, disability, marital status, amnesty, or veteran status, as covered by federal, state, and local laws. We comply with relevant state and local non-discrimination employment laws in all locations where we operate.
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